Metabolic Effects of Switching Kaletra to Boosted Reyataz
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00413153 |
Recruitment Status
:
Completed
First Posted
: December 19, 2006
Results First Posted
: March 3, 2010
Last Update Posted
: March 9, 2010
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: atazanavir/ritonavir Drug: lopinavir/ritonavir | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Metabolic Effects of Switching Kaletra to Boosted Reyataz |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
|
Drug: atazanavir/ritonavir
atazanavir 300mg + ritonavir 100mg once daily
Other Name: Boosted Reyataz
|
Active Comparator: 2
Kaletra (pre-study dose)
|
Drug: lopinavir/ritonavir
patient remains on their pre-study dose of lopinavir/ritonavir
Other Name: Kaletra
|
- Glucose Trafficking [ Time Frame: 6 months ]6 month mean and standard deviation for glucose uptake into anterior thigh muscle as measured by FDG/PET scanning during euglycemic hyperinsulinemic clamp. During the hyperinsulinemic conditions of the clamp, glucose and 18-FDG [labeled glucose] are taken up by muscle. The quantity of 18-FDG taken up is measured by the PET scan. Although there are no well-accepted norms for this measurement, a higher value indicates that more glucose is being taken up by (or "trafficked to") muscle. Increased uptake of glucose indicates increased muscle insulin sensitivity.
- Insulin Sensitivity [ Time Frame: 6 months ]6 month mean and standard deviation for insulin-stimulated glucose uptake (M) per unit insulin at 120 minutes as measured by euglycemic hyperinsulinemic clamp.
- Fasting Glucose [ Time Frame: 6 months ]6 month mean and standard deviation for fasting glucose.
- Lipid Metabolism - Serum Triglyceride [ Time Frame: 6 months ]6 month mean and standard deviation for serum triglyceride.
- Body Composition - Visceral Adipose Tissue [ Time Frame: 6 months ]6 month mean and standard deviation for visceral adipose tissue (VAT) as measured by single slice computed tomography (CT) scan at the L4 pedicle (pedicle of 4th lumbar vertebra).
- Immune Parameters -- CD4 Count [ Time Frame: 6 months ]6 month mean and standard deviation for CD4+ count.
- Liver Enzymes -- Aspartate Aminotransferase (AST) [ Time Frame: 6 months ]6 month mean and standard deviation for AST.
- Liver Enzymes -- Alanine Aminotransferase (ALT) [ Time Frame: 6 months ]6 month mean and standard deviation for ALT.
- Total Bilirubin [ Time Frame: 6 months ]6 month mean and standard deviation for total bilirubin.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previously diagnosed HIV infection
- Age between 18-65 years
- Stable antiviral regimen containing at least 2 nucleoside reverse transcriptase inhibitors (NRTI's) and LPV/r for ³ 6 mos
- CD4 count > 400 cell/mm3
- Metabolic complication as indicated by one or more of hyperinsulinemia (fasting insulin >= 15 mIU/ml), hypercholesteremia (fasting total cholesterol >= 200 mg/dL), hypertriglyceridemia (fasting triglycerides >= 150 mg/dL), or treatment with a lipid lowering medication.
Exclusion Criteria:
- Hemoglobin < 11.0 g/dL
- History of Diabetes Mellitus
- Currently on medication for Diabetes
- Therapy with glucocorticoid, growth hormone or other anabolic agents currently or within the past 3 months
- Current substance abuse, including alcohol, cocaine and/or heroin
- Any contraindication to ATV/r or known allergy to ATV
- Concurrent therapy with: Bepridil; cisapride; ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine); indinavir; irinotecan; lovastatin; midazolam; pimozide; proton pump inhibitors (esomeprazole, lansoprazole, omeprazole); rifampin; simvastatin; St John's wort; or triazolam
- New or serious opportunistic infection in the past 3 months
- Pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413153
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Steven K Grinspoon, MD | MGH |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Steven K. Grinspoon, MD, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00413153 History of Changes |
Other Study ID Numbers: |
2005-P-002239 |
First Posted: | December 19, 2006 Key Record Dates |
Results First Posted: | March 3, 2010 |
Last Update Posted: | March 9, 2010 |
Last Verified: | March 2010 |
Keywords provided by Massachusetts General Hospital:
HIV Kaletra Reyataz Insulin sensitivity |
Lipids Body Composition Receiving Kaletra Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir |
Atazanavir Sulfate HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |